NEPTUNUS Match Study (NEPTUNE Match)
Nefrotisch Syndroom Study Network (NEPTUNE) Match Study
NEPTUNE Match is an additional opportunity offered to NEPTUNE study participants to prospectively recruit and communicate patient-specific clinical trial matching with kidney patients and their physician investigators.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This is a prospective, open-label study testing the ability to effectively communicate patient-specific clinical trial matching with kidney patients and clinician investigators. The study consists of four components:
- Recruitment of participants from the NEPTUNE observational cohort study
- Generation of participant profile-trial match assessment using data from the NEPTUNE observational study and profiling units by the NEPTUNE Molecular Nephrology Board
- Establishing and testing a framework to communicate disease-trial drug mechanism matching with investigators and patients
- Retrospective comparison of kidney health outcomes in subjects enrolled in trials that aligned with their match vs. trial subjects with mis-aligned or unknown match alignment.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Hailey E Desmond, MS
- Telefoonnummer: 734-232-4851
- E-mail: heturner@med.umich.edu
Studie Contact Back-up
- Naam: Chrysta C Lienczewski, BS
- Telefoonnummer: 734-615-5021
- E-mail: boridley@med.umich.edu
Studie Locaties
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
- Werving
- Emory University Hospital - Children's Hospital of Atlanta
-
Hoofdonderzoeker:
- Laurence Greenbaum, MD, PhD
-
Contact:
- Emily Yun
- E-mail: emily.yun@emory.edu
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Illinois
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Chicago, Illinois, Verenigde Staten, 60612
- Werving
- John H. Stroger, Jr., Hospital of Cook County
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Contact:
- Mathew Itteera
- E-mail: mathew.itteera@cookcountyhhs.org
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Kansas
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Kansas City, Kansas, Verenigde Staten, 66160
- Werving
- University of Kansas Medical Center
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Contact:
- Catherine Creed
- E-mail: ccreed@kumc.edu
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Hoofdonderzoeker:
- Ellen McCarthy, MD
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21287
- Werving
- Johns Hopkins Medicine
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Contact:
- MIahje Williams
- E-mail: mwil296@jhmi.edu
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Hoofdonderzoeker:
- Meredith Adkinson, MD
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109
- Aanmelden op uitnodiging
- University of Michigan
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Missouri
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Kansas City, Missouri, Verenigde Staten, 64108
- Werving
- Children's Mercy Hospital
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Hoofdonderzoeker:
- Tarak Srivastava, MD
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Contact:
- Kelsey Markus
- E-mail: kemarkus@cmh.edu
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New York
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New Hyde Park, New York, Verenigde Staten, 11040
- Werving
- Northwell/Cohen's Children's Hospital
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Contact:
- Suzanne Vento, BSN
- E-mail: svento@northwell.edu
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Hoofdonderzoeker:
- Christine Sethna, MD, MS
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New York, New York, Verenigde Staten, 10032
- Werving
- Columbia University Medical Center
-
Contact:
- Anup Pradhan
-
Hoofdonderzoeker:
- Pietro Canetta, MD
-
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27514
- Werving
- University of North Carolina Chapel Hill
-
Contact:
- Anne Froment
- E-mail: anne_froment@med.unc.edu
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Contact:
- Maria Fernanda Ochoa Toro
- E-mail: ferochoc@email.unc.edu
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Hoofdonderzoeker:
- Vimal Derebail, MD, MS
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44106
- Werving
- Cleveland Clinic Foundation
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Contact:
- Stefanie Larson
- E-mail: larsons2@ccf.org
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Hoofdonderzoeker:
- Katherine Dell, MD
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Werving
- Hospital of the University of Pennsylvania
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Contact:
- Krishna Kallem, MS
- E-mail: Krishna.Kallem@pennmedicine.upenn.edu
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Hoofdonderzoeker:
- Larry Holzman, MD
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Philadelphia, Pennsylvania, Verenigde Staten, 19122
- Werving
- Temple University
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Hoofdonderzoeker:
- Iris Lee, MD
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Contact:
- Zoe Pfeffer
- E-mail: zoe.pfeffer@tuhs.temple.edu
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South Carolina
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Charlotte, South Carolina, Verenigde Staten, 29425
- Werving
- Medical University of South Carolina
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Hoofdonderzoeker:
- David Selewski, MD, MS
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Washington
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Seattle, Washington, Verenigde Staten, 98195
- Werving
- University of Washington Medical Center
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Contact:
- Linda Manahan, BSN
- E-mail: lmanahan@nephrology.washington.edu
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Hoofdonderzoeker:
- Ashley Jefferson, MD
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Seattle, Washington, Verenigde Staten, 98105
- Werving
- Seattle Children's Hospital
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Contact:
- Emily Pao
- E-mail: emily.pao@seattlechildrens.org
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Hoofdonderzoeker:
- Sangeeta Hingorani, MD
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Spokane, Washington, Verenigde Staten, 99204
- Werving
- Providence Sacred Heart Medical Center
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Hoofdonderzoeker:
- Katherine Tuttle, MD
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Contact:
- Kelli Kuykendall
- E-mail: kelli.kuykendall@providence.org
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
-
Consented and eligible participants in the biopsied or non-biopsied cohorts of the NEPTUNE observational study
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Must be potentially eligible for the NEPTUNE Match partnering trials (e.g. if no trial is enrolling a participant under age 6, those under 6 are not eligible).
Note: NEPTUNE Match partnering trials and associated eligibility criteria are expected to be dynamic and change as trial protocols are developed, activated, and amended.
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Regular nephrology healthcare provided at a NEPTUNE study site.
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Willing and able to consent, and as appropriate assent, to participate in NEPTUNE Match
Exclusion Criteria:
Currently non-NEPTUNE observational study participants are not eligible to be matched to a clinical trial using these biomarker assessments.
Exclusion Criteria:
1. Non-English or non-Spanish speaking
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: NEPTUNE Match Participants
Approximately 375 participants will be consented from the NEPTUNE observational study with age and demographic groups representing the patient population in the NEPTUNE study site geographical areas. NEPTUNE observational cohort eligibility includes: participants in NEPTUNE observational cohort A are of any age and have a biopsy-confirmed diagnosis of Focal Segmental Glomerulosclerosis (FSGS), Minimal Change Disease (MCD), or Membranous Nephropathy (MN). Participants in NEPTUNE observational cohort B have documented NS based on proteinuria, serum albumin, and/or edema with age of onset less than 19 years. |
The NEPTUNE Match study includes an interdisciplinary Communication Team that will translate findings from the Molecular Nephrology Board (MNB) to inform patients of the matching assessment with ongoing clinical trials. This team has considerable experience with conveying complex biomedical research information to patients and families and includes experts in precision nephrology, nephrology patient [adult and pediatric] communication, and health education. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Matched participants with at least one clinical trial receive a MNB assessment
Tijdsspanne: 0-4 weeks
|
Proportion of NEPTUNE Match participants with at least one matching clinical trial, defined as receiving a Molecular Nephrology Board (MNB) assessment that provides a match to at least one targeted therapy in an ongoing clinical trial |
0-4 weeks
|
|
Efficacy of communication methods at time of communication visit, measured by Teach Back 1 summary score
Tijdsspanne: 12 weeks
|
Key findings from MNB trial matching analyses and deliberations will be conveyed to study participants using a NEPTUNE Match Report that summarizes the findings. The report indicates the strength of matching to ongoing clinical trials and the uncertainty and research origins of the information. A sample Match Report can be found in Appendix C. The report will not contain individual data elements reviewed by the MNB. The creation of NEPTUNE Match Reports will follow health education principles including matching of content to patients' informational needs and health literacy levels, use of visual aids to clarify meaning of information, and avoidance of information overload of the participant. |
12 weeks
|
|
Kidney health endpoints that are specific to each individual trial
Tijdsspanne: 0-60 months
|
The analytic integration supporting the Molecular Nephrology Board (MNB) case review will be initiated and will occur. The MNB will conduct the discussion and generate the integrated data summary and case report inclusive of clinical trial matching by webinar. Input from the MNB will be used to generate a final version of the participant NEPTUNE Match Report. This is a longitudinal outcome that will be assessed at the end of the study relative to endpoints specific to matched clinical trials, assessing the superiority of stratification (matching or alignment of patient molecular profiles to targeted therapies in clinical trials) to non-stratification. |
0-60 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Efficacy of communication methods at follow up, measured by Teach Back of key concepts
Tijdsspanne: 14-18 weeks
|
3 defined teachback concepts will be scored to indicate the participant's understanding of strength of matching. |
14-18 weeks
|
|
Psychological distress measured by the STAI assessment
Tijdsspanne: 14-18 weeks
|
State Trait Anxiety Inventory (mini-STAI) scale will be used to assess a participant's psychological distress around their participation in NEPTUNE Match at the consent visit and the follow up visit. |
14-18 weeks
|
|
Psychological distress measured by the FACToR-NEPTUNE assessment
Tijdsspanne: 14-18 weeks
|
FACToR-NEPTUNE is a measure that has been modified from the Feelings About genomiC Testing Results (FACToR). FACToR-12 is used to assess the psychosocial impact of returning genomic findings to patients in research and clinical practice. In the FACToR-NEPTUNE assessment the measure will assess the psychosocial impact after receiving the NEPTUNE Match Report. |
14-18 weeks
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Matthias Kretzler, MD, University of Michigan
Publicaties en nuttige links
Algemene publicaties
- Gadegbeku CA, Gipson DS, Holzman LB, Ojo AO, Song PX, Barisoni L, Sampson MG, Kopp JB, Lemley KV, Nelson PJ, Lienczewski CC, Adler SG, Appel GB, Cattran DC, Choi MJ, Contreras G, Dell KM, Fervenza FC, Gibson KL, Greenbaum LA, Hernandez JD, Hewitt SM, Hingorani SR, Hladunewich M, Hogan MC, Hogan SL, Kaskel FJ, Lieske JC, Meyers KE, Nachman PH, Nast CC, Neu AM, Reich HN, Sedor JR, Sethna CB, Trachtman H, Tuttle KR, Zhdanova O, Zilleruelo GE, Kretzler M. Design of the Nephrotic Syndrome Study Network (NEPTUNE) to evaluate primary glomerular nephropathy by a multidisciplinary approach. Kidney Int. 2013 Apr;83(4):749-56. doi: 10.1038/ki.2012.428. Epub 2013 Jan 16.
- Tao J, Mariani L, Eddy S, Maecker H, Kambham N, Mehta K, Hartman J, Wang W, Kretzler M, Lafayette RA. JAK-STAT signaling is activated in the kidney and peripheral blood cells of patients with focal segmental glomerulosclerosis. Kidney Int. 2018 Oct;94(4):795-808. doi: 10.1016/j.kint.2018.05.022. Epub 2018 Aug 6.
- Ha Dinh TT, Bonner A, Clark R, Ramsbotham J, Hines S. The effectiveness of the teach-back method on adherence and self-management in health education for people with chronic disease: a systematic review. JBI Database System Rev Implement Rep. 2016 Jan;14(1):210-47. doi: 10.11124/jbisrir-2016-2296.
- Tluczek A, Henriques JB, Brown RL. Support for the reliability and validity of a six-item state anxiety scale derived from the State-Trait Anxiety Inventory. J Nurs Meas. 2009;17(1):19-28. doi: 10.1891/1061-3749.17.1.19.
- Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
Nuttige links
- <p>Redefining Nephrotic Syndrome in Molecular Terms: Outcome-associated molecular clusters and patient stratification with noninvasive surrogate biomarkers</p>
- <p>Teachback</p>
- <p>Are physicians and patients in agreement? Exploring dyadic concordance</p>
- <p>Patients' memory for medical information</p>
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Mannelijke urogenitale ziekten
- Nier Ziekten
- Urologische ziekten
- Vrouwelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Bindweefselziekten
- Auto-immuunziekten
- Ziekten van het immuunsysteem
- Aangeboren afwijkingen
- Urogenitale afwijkingen
- Glomerulonefritis
- Nefritis
- Collageen Ziekten
- Nefrose
- Aangeboren, erfelijke en neonatale ziekten en afwijkingen
- Huid- en bindweefselaandoeningen
- Nefrotisch syndroom
- Glomerulonefritis, membraanachtig
- Glomerulosclerose, focaal segmentaal
- Nefritis, erfelijk
- Nefrose, Lipoïde
- Maculaire dystrofie, hoornvliestype 1
Andere studie-ID-nummers
- HUM00158219-Sub
- U54DK083912 (Subsidie/contract van de Amerikaanse NIH)
- R01DK141114 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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